Light, Operating, Dental
Dental · 21 CFR 872.4630
Recent MDR events
180 adverse event reports on file
- MIDMARKJun 19, 2026MalfunctionMidmark Corporation1523530-2026-00006
- MIDMARKJan 30, 2026MalfunctionMidmark Corporation1523530-2026-00001
- RITTERJan 2, 2026MalfunctionMidmark Corporation1523530-2025-00008
- FLEXIBLE MONITOR MOUNTS, FMM - CEILING MOUNTEDOct 7, 2025InjuryKavo Dental Technologies, Llc1017522-2025-00003
- MIDMARKAug 18, 2025MalfunctionMidmark Corporation1523530-2025-00007
- MIDMARKApr 16, 2025MalfunctionMidmark Corporation1523530-2025-00002
- MIDMARKFeb 14, 2025InjuryMidmark Corporation1523530-2025-00001
- MIDMARKAug 23, 2024MalfunctionMidmark Corporation1523530-2024-00008
- MIDMARKAug 21, 2024MalfunctionMidmark Corporation1523530-2024-00007
- RITTERAug 2, 2024MalfunctionMidmark Corporation1523530-2024-00006
Event type breakdown
Recalls
3 recall events for this product code
- Dental Equipment LLCTerminatedJul 15, 2011
LuxStar Dental Light have the following Agency model or Catalog Model numbers as ML1000, OL1000, CL1000, WL1000, CB1000, TL1000, and UL1000.
Lens heat shield (birdcage) of the Luxstar Dental Light could fall and injure a patient.
Z-2834-2011 · View FDA record ↗ - Dental Equipment LLCTerminatedJul 12, 2007
DCI Equipment Track Mount Light Assembly, 110v
Potential for light shield to melt due to light assemblies not properly rated to handle the VAC.
Z-1077-2007 · View FDA record ↗ - Pelton & Crane / Marus / DCI Equipment / KaVoTerminatedUnknown
Helios HL3T and HLT Track Mounted Dental Lights
The firm received two customer complaints local Pelton & Crane distributors that the Helios 3000 track mounted dental lights were missing the two 8/32x3/16 set screws during the initial installation of the dental light.
Z-1268-2016 · View FDA record ↗
Registered firms
82 firms currently registered for this product code
Beyes Dental Inc
Toronto Ontario, CA
Aiobio Co., Ltd.
Seongnam-si Gyeonggi, KR
Chuan Fu Medical Instrument Co., Ltd
Taoyuan City, TW
Olsen Industria E Comercio S/a
Palhoca Santa Catarina, BR
Dci International, Llc
NEWBERG, OR, US
Takara Belmont Corporation, Osaka Factory
OSAKA, JP
Dentalez Of Alabama
BAY MINETTE, AL, US
Forest Dental Equipment
HILLSBORO, OR, US
Ascentcare Dental Products
Grand Haven, MI, US
A-dec, Inc.
Newberg, OR, US
Kavo Dental Technologies, Llc
CHARLOTTE, NC, US
Lakong Medical Devices Co., Ltd.
Dongguan Guangdong, CN
Dhef Inc.
NEW TAIPEI CITY, TW
Dexta Corp.
NAPA, CA, US
Reko Dental, Llc
GARDENA, CA, US
Dentamerica
City of Industry, CA, US
Dentsply Sirona Inc
York, PA, US
J. Morita Mfg. Corp.
FUSHIMI-KU Kyoto, JP
Dongguan Wanjin Industrial Co., Ltd
DongGuang Guangdong, CN
Shanghai Greeloy Industry Co., Ltd
Shanghai, CN
Summit Dental Systems Llc.
Fort Lauderdale, FL, US
Midmark Corporation
Versailles, OH, US
Dental Technologies, Inc.
Lincolnwood, IL, US
Kuang Yeu Medical Co., Ltd.
Taichung City, TAIWAN, TW
Boyd Industries, Inc.
CLEARWATER, FL, US
510(k) clearances
23 clearances for this product code
- Addent, Inc.Nov 19, 2007
K072309 · MICROLUX/BLU
- Addent, Inc.Apr 4, 2005
K041614 · MICROLUX DL
- Trylon Corp.Nov 22, 2004
K033033 · VIZILITE-BLUE ORAL EXAM KIT
- Trylon Corp.Mar 16, 2001
K003995 · SPECULITE/ORALLITE
- Mdt Corp., Inc.Jan 26, 1994
K926081 · DENTAL LIGHT
- Pelton & Crane Co.Dec 10, 1993
K935390 · SIROLUX FANTASTIC
- Den-Tal-Ez Mfg Co., Inc.Nov 23, 1993
K925629 · ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT
- Planmeca USA, Inc.Dec 21, 1992
K923462 · DELIGHT